Use of a preparation of cimicifuga racemosa

ABSTRACT

A preparation of  Cimicifuga racemosa  can be used to successfully treat urinary incontinence in female mammals following an ovariohysterectomy. Positive results can also be expected for the treatment of women following a hysterectomy or after the menopause.

The invention relates to the use of a preparation of Cimicifuga racemosa(Black Snakeroot), in particular an extract thereof, and moreparticularly an extract of the rhizome (Rhizoma cimicifugae racemosae).

Extracts of Cimicifuga racemosa are used in gyniatrics for the treatmentof menopause complaints, such as hot flushes, sweating, sleep disorders,irritability, and depressive disgruntlement. The extract is regarded asa phytosubstitute for oestrogen replacement therapy. Extracts ofCimicifuga racemosa play no significant role in allopathic veterinarymedicine.

It has been found, surprisingly, that preparations of Cimicifugaracemosa are therapeutically effective against urinary incontinence.

It is known that approximately 20% of bitches which have been subjectedto castration, ie excision of the ovaries, and possibly also of theuterus, suffer from urinary incontinence as a secondary symptom of theoperation after the elapse of approximately 2.7 years on averagefollowing ovariohysterectomy. The clinical symptoms are nowadaysprimarily treated with sympathomimetics, which, however, cause seriousside effects in animals not optimally adjusted.

It was formerly assumed that this urinary incontinence was a result ofthe oestrogen deficiency induced by the operation. Despite doubtsconcerning such causality, aroused by the fact that the clinical picturedoes not occur prior to an elapse of an average of 2.7 years followingovariectomy, attempts have been made to treat the symptoms by oestrogenreplacement. These doubts, combined with the side effects occurringduring therapy have led to increased consideration of effectingtreatment with sympathomimetics.

In women over 60 and having a basal incontinence incidence of from 10 to33%, hysterectomy, ie the removal of the uterus but not the ovaries, iewithout additionally influencing the hormonal status, raises theprobability of developing urinary incontinence by 60%. Lesions caused bythe operation on nerves and ligamentary connective tissue structures inthe pelvic region are under discussion as being the cause of the problem(Lancet 2000; 356(9229): 535-539). Lesions of the same kind alsocommonly occur with the operative technique typically used in veterinarymedicine. The effectiveness of the preparation of Cimicifuga racemosa ofthe invention for the treatment of urinary incontinence is thus notbased on the properties hitherto ascribed to Cimicifuga racemosa asoestrogen substitute or as endocrinally active phytotherapeutic butrather on effects beyond known properties.

Although one must be cautious when considering applying veterinarycausal and therapeutic findings to human syndromes, the results foundsuggest efficacy for the treatment of urinary incontinence inovariectomized women or permenopausal or postmenopausal women. Theoccurrence of urinary incontinence in postmenopausal women is between 20and 50% depending on age. No increase is observed in the perimenopause.Early oestrogen replacement is associated with slight symptomimprovement on a short term basis only, whilst in the long run it isassociated with an increase in the incontinence risk in women over 60,as has been shown in a published study (D. H. Thom, J. S. Brown in J.Am. Geriatr. Soc. 1998; 46(11): 1411-1417).

Thus the prior state of knowledge could not have suggested the presentlyproposed use of Cimicifuga racemosa for treatment of urinaryincontinence and is unable to provide an explanation of the observedsuccess thereof.

An effective daily dosage for the application proposed by the inventionhas been found to be a drug content of between 0.1 and 10 mg/kg of bodyweight. Thus it is advantageous to formulate an extract as tabletshaving a drug content of between 5 and 200 mg, and preferably between 10and 50 mg, per tablet.

In the present invention, it is preferred to use an extract which hasbeen prepared using an alcoholic extracting agent, particularly ethanol,isopropanol, or methanol.

Administration can be accomplished using any of the commonly usedpharmaceutical administration forms, such as granules, capsules,suppositories, tablets, solutions, tea preparations, or by transdermalmeans, such as a plaster or the like.

It is also suitable as an additive for food or fodder.

The preparation must not necessarily be administered as an extract Forexample, it is possible to grind the plant or portions thereof fordirect or indirect ingestion, for example, as tea.

Therapy involving the preparation of Cimicifuga racemosa as proposed inthe invention is particularly suitably for female mammals following anovariohysterectomy and for women following a hysterectomy or after themenopause.

EXAMPLE

Ovariectomized bitches showing the symptomatic complex of urinaryincontinence were treated with an extract of Rhizoma cimicifugaeracemosae in the form of tablets (“Remlfemin” tablets, sold by Schaper &Brummer GmbH & Co. KG). An effective daily intake of from one half toone whole tablet per 10 kg of body weight was used. In all of thefourteen cases treated there was remittence of the incontinence. Thesubjective judgement of the owners of the treated bitches on thetherapeutic success and the compatibility of the pharmaceuticalpreparation was positive in all cases. In all cases, the owners askedfor continuation of the therapy. In all cases there was distinctimprovement of condition going, in some cases, as far as completesubsidence of the complaint.

The Remifemin® tablets used contain an extract of 20 mg of drug pertablet. The extracting agent used was isopropanol 40 vol %.

What is claimed is:
 1. A method for treatment of urinary incontinence,comprising administering, to a patient, a preparation of Cimicifugaracemosa.
 2. The treatment method of claim 1, wherein the preparationcomprises an extract of Cimicifuga racemosa.
 3. The treatment method asclaimed in claim 2, wherein the extract has been produced using analcoholic extracting agent.
 4. The treatment method as claimed in claim2, wherein the preparation is in the form of tablets having Cimicifugaracemosa content of between 5 and 200 mg per tablet.
 5. The treatmentmethod as claimed in claim 1, wherein an additive for supplementedfodder is administered.
 6. The treatment method as claimed in claim 3,wherein the Cimicifuga racemosa administering is in the form of tabletshaving Cimicifuga racemosa content of between 5 and 200 mg per tablet.7. The treatment method according to claim 1, wherein Cimicifugaracemosa is administered in a range of between 0.1 and 10 mg Cimicifugaracemosa per kg of body weight.
 8. The treatment method according toclaim 1, comprising Cimicifuga racemosa administration to one selectedfrom the group consisting of: a female mammal following anovariohysterectomy; a woman following a hysterectomy and a woman aftermenopause.
 9. The treatment method of claim 1, wherein Rhizomacimicifugae racemosae is administered.